A Study to Evaluate Single Doses of Alpha-0261 in Healthy... | NCT07279636

Studies
A Study to Evaluate Single Doses of Alpha-0261 in Healthy Adult Volunteers

NCT07279636

Sponsor

AlphaMol Science Ltd. (Shanghai)

Status

Completed

Last Update Posted

Jun 30, 2026Actual

Enrollment

55Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

Alpha-0261
Placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 21, 2025Actual

Primary Completion Date

Feb 14, 2026Actual

Completion Date

Apr 15, 2026Actual

First Submitted Date

Nov 29, 2025

First Submission Date that Met QC Criteria

Dec 10, 2025

First Posted Date

Dec 12, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2026

Last Update Posted Date

Jun 30, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of Alpha-0261 tablets after single oral administration in healthy adult volunteers.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Ascending Dose	Experimental		Drug: Alpha-0261
Single Ascending Dose (placebo)	Placebo Comparator		Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alpha-0261	Drug	Oral, tablet	Single Ascending Dose
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of treatment emergent adverse events		From enrollment to end of follow-up visit, up to approximately 1 week

Secondary Outcomes

Measure	Description	Time Frame
Plasma PK of Alpha-0261 after single dose	Maximum Plasma Concentration (Cmax)	From enrollment to end of treatment period, up to approximately 7 days
Plasma PK of Alpha-0261 after single dose

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged ≥ 18 and ≤ 55, male or female
Weight: ≥ 50 kg for males, ≥ 45 kg for females; 19 kg/m2 ≤ body mass index (BMI) ≤ 28 kg/m2
In general good health

Exclusion Criteria:

Have a history of any severe allergic reaction or anaphylaxis
Any condition, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol
Have clinically significant abnormalities on clinical laboratory results

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bishan Hospital of Chongqing		Chongqing			China