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| Name | Class |
|---|---|
| Aiolos Bio, Inc. | INDUSTRY |
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This goal of the open-label single dose study is to evaluate and compare the safety, tolerability, pharmacokinetic (PK), and immunogenicity of AIO-001 using two different formulations in 16 healthy volunteers.
This is an open-label single dose, parallel group, 24-week, Phase 1 study in 16 healthy participants.
The study is designed to evaluate and compare the safety, tolerability, PK, and immunogenicity of AIO-001 using two different formulations (Formulation A and Formulation B) in 16 healthy volunteers (8 receiving each formulation).
The study will include a screening visit from Day -28 to Day -2. Eligible participants will be admitted to the clinical site on Day -1 and will be confined until completion of the assessments on Day 3. Participants will return to the clinical site for outpatient visits for study assessments and laboratory tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIO-001 (Formulation A) | Experimental | 400 milligram (mg) of 100 milligrams per milliliter (mg/ml) AIO-001 Subcutaneous (SC) injection will be administered. |
|
| AIO-001 (Formulation B) | Experimental | 400 mg of 182 mg/ml AIO-001 SC injection will be administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIO-001 | Drug | AIO-001 Solution for SC injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An AE was defined as any untoward medical occurrence in a participant or clinical trial participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. TEAEs were defined as AEs that commence on or after the time of study drug administration. | From Day 1 up to Day 169 |
| Number of Participants With Clinically Significant Changes in Vital Signs | Vital sign measurements included blood pressure, heart rate, respiratory rate, and oral temperature measurements. The clinically significant changes were based on investigator's judgement. | Baseline (Day -1) up to Day 169 |
| Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram Parameters | The electrocardiogram parameters included heart rate, PR interval, QT interval, corrected QT (QTcF using Fridericia's formula) interval and QRS. The clinically significant changes were based on investigator's judgement. | Baseline (Day -1) up to Day 169 |
| Number of Participants With Clinically Significant Changes in Physical Examination Findings | Physical examination included assessments of the following: head, eyes, ears, nose, throat, neck, chest, lungs, abdomen, musculoskeletal, dermatological, cardiovascular/peripheral vascular, and general neurological examination. The clinically significant changes were based on investigator's judgement. | Baseline (Day -1) up to Day 169 |
| Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC0-last) of AIO-001 | Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of AIO-001. PK analysis was conducted using standard non-compartmental methods. | Pre-dose, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360, and 4056 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Principal Investigator | Nucleus Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Q-Pharm Pty Ltd | Herston | Queensland | 4006 | Australia |
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: Sharing Clinical Trial Data' on the GSK Study Register (www.gsk-studyregister.com).
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Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | AIO-001: Formulation A | Participants received 400 milligrams (mg) of 100 milligrams per milliliter (mg/ml) AIO-001, administered as 4*1.0 milliliter (ml) subcutaneous (SC) injection on Day 1. |
| FG001 | AIO-001: Formulation B | Participants received 400 mg of 182 mg/ml AIO-001, administered as 2*1.1 ml SC injection on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | AIO-001: Formulation A | Participants received 400 mg of 100 mg/ml AIO-001, administered as 4*1.0 ml SC injection on Day 1. |
| BG001 | AIO-001: Formulation B | Participants received 400 mg of 182 mg/ml AIO-001, administered as 2*1.1 ml SC injection on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An AE was defined as any untoward medical occurrence in a participant or clinical trial participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. TEAEs were defined as AEs that commence on or after the time of study drug administration. | The safety population included all participants who received at least one dose of the study drug. | Posted | Count of Participants | Participants | From Day 1 up to Day 169 |
|
All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169
The safety population included all participants who received at least one dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AIO-001: Formulation A | Participants received 400 mg of 100 mg/ml AIO-001, administered as 4*1.0 ml SC injection on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@GSK.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 29, 2023 | Jun 18, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 22, 2024 | Jun 18, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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Clinical laboratory parameters included biochemistry, hematology, and urinalysis assessment. The clinically significant changes were based on investigator's judgement. |
| Baseline (Day -1) up to Day 169 |
| Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of AIO-001 | Blood samples were collected at indicated time points for PK analysis of AIO-001. PK analysis was conducted using standard non-compartmental methods. The residual area was greater than 20% in 15 out of the total of 16 participants and therefore the estimation of AUC0-inf may be non-identifiable. | Pre-dose, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360, and 4056 hours post-dose |
| Maximal Observed Concentration (Cmax) of AIO-001 | Blood samples were collected at indicated time points for PK analysis of AIO-001. PK analysis was conducted using standard non-compartmental methods. | Pre-dose, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360, and 4056 hours post-dose |
| Time to Maximal Observed Concentration (Tmax) of AIO-001 | Blood samples were collected at indicated time points for PK analysis of AIO-001. PK analysis was conducted using standard non-compartmental methods. | Pre-dose, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360, and 4056 hours post-dose |
| Terminal Elimination Half-life (T½) of AIO-001 | Blood samples were collected at indicated time points for PK analysis of AIO-001. PK analysis was conducted using standard non-compartmental methods. The residual area was greater than 20% in 15 out of the total of 16 participants and therefore the estimation of T½ may be non-identifiable. | Pre-dose, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360, and 4056 hours post-dose |
| Number of Participants With Positive Anti-drug Antibody (ADA) to AIO-001 | ADA-positive participant was defined as participant with at least one treatment-induced or treatment-boosted ADA-positive sample at any time during the treatment or follow-up observation period. Anti-AIO-001 antibodies were evaluated in serum samples. Serum samples were screened for antibodies binding to AIO-001. | Up to Day 169 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | AIO-001: Formulation B | Participants received 400 mg of 182 mg/ml AIO-001, administered as 2*1.1 ml SC injection on Day 1. |
|
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| Primary | Number of Participants With Clinically Significant Changes in Vital Signs | Vital sign measurements included blood pressure, heart rate, respiratory rate, and oral temperature measurements. The clinically significant changes were based on investigator's judgement. | The safety population included all participants who received at least one dose of the study drug. | Posted | Count of Participants | Participants | Baseline (Day -1) up to Day 169 |
|
|
|
| Primary | Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram Parameters | The electrocardiogram parameters included heart rate, PR interval, QT interval, corrected QT (QTcF using Fridericia's formula) interval and QRS. The clinically significant changes were based on investigator's judgement. | The safety population included all participants who received at least one dose of the study drug. | Posted | Count of Participants | Participants | Baseline (Day -1) up to Day 169 |
|
|
|
| Primary | Number of Participants With Clinically Significant Changes in Physical Examination Findings | Physical examination included assessments of the following: head, eyes, ears, nose, throat, neck, chest, lungs, abdomen, musculoskeletal, dermatological, cardiovascular/peripheral vascular, and general neurological examination. The clinically significant changes were based on investigator's judgement. | The safety population included all participants who received at least one dose of the study drug. | Posted | Count of Participants | Participants | Baseline (Day -1) up to Day 169 |
|
|
|
| Primary | Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters | Clinical laboratory parameters included biochemistry, hematology, and urinalysis assessment. The clinically significant changes were based on investigator's judgement. | The safety population included all participants who received at least one dose of the study drug. | Posted | Count of Participants | Participants | Baseline (Day -1) up to Day 169 |
|
|
|
| Secondary | Area Under the Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC0-last) of AIO-001 | Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of AIO-001. PK analysis was conducted using standard non-compartmental methods. | The PK population included all participants who had at least 1 measured PK concentration following dosing. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*microgram per milliliter(day*mcg/mL) | Pre-dose, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360, and 4056 hours post-dose |
|
|
|
| Secondary | Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of AIO-001 | Blood samples were collected at indicated time points for PK analysis of AIO-001. PK analysis was conducted using standard non-compartmental methods. The residual area was greater than 20% in 15 out of the total of 16 participants and therefore the estimation of AUC0-inf may be non-identifiable. | The PK population included all participants who had at least 1 measured PK concentration following dosing. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*mcg/mL | Pre-dose, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360, and 4056 hours post-dose |
|
|
|
| Secondary | Maximal Observed Concentration (Cmax) of AIO-001 | Blood samples were collected at indicated time points for PK analysis of AIO-001. PK analysis was conducted using standard non-compartmental methods. | The PK population included all participants who had at least 1 measured PK concentration following dosing. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (mcg/mL) | Pre-dose, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360, and 4056 hours post-dose |
|
|
|
| Secondary | Time to Maximal Observed Concentration (Tmax) of AIO-001 | Blood samples were collected at indicated time points for PK analysis of AIO-001. PK analysis was conducted using standard non-compartmental methods. | The PK population included all participants who had at least 1 measured PK concentration following dosing. | Posted | Median | Full Range | day | Pre-dose, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360, and 4056 hours post-dose |
|
|
|
| Secondary | Terminal Elimination Half-life (T½) of AIO-001 | Blood samples were collected at indicated time points for PK analysis of AIO-001. PK analysis was conducted using standard non-compartmental methods. The residual area was greater than 20% in 15 out of the total of 16 participants and therefore the estimation of T½ may be non-identifiable. | The PK population included all participants who had at least 1 measured PK concentration following dosing. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | day | Pre-dose, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360, and 4056 hours post-dose |
|
|
|
| Secondary | Number of Participants With Positive Anti-drug Antibody (ADA) to AIO-001 | ADA-positive participant was defined as participant with at least one treatment-induced or treatment-boosted ADA-positive sample at any time during the treatment or follow-up observation period. Anti-AIO-001 antibodies were evaluated in serum samples. Serum samples were screened for antibodies binding to AIO-001. | The immunogenicity population included all participants who received any amount of AIO-001 and had at least one post-dose ADA measurement. | Posted | Count of Participants | Participants | Up to Day 169 |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 5 |
| 8 |
| EG001 | AIO-001: Formulation B | Participants received 400 mg of 182 mg/ml AIO-001, administered as 2*1.1 ml SC injection on Day 1. | 0 | 8 | 0 | 8 | 6 | 8 |
| Pneumonia | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
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| Tooth infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 26.1 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA Version 26.1 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
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| Troponin I increased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
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| Myokymia | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
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