Study of Multiple Doses of PRS-060 Administered by Oral Inhalation in Subjects With Mild Asthma

A Dose-Escalating, Single-Blind Study to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of PRS-060 Administered by Oral Inhalation in Subjects With Mild Asthma

Study of Multiple Doses of PRS-060 Administered by Oral Inhalation in Subjects with Mild Asthma

PRS-060 is a drug candidate being developed for the treatment of asthma. The main purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of multiple doses of PRS-060 administered by inhalation in subjects with mild asthma.

Inclusion Criteria:

• Body Mass Index (BMI) of 18 to 35
• Subjects who are non-smokers or ex-smokers who have smoked no more than twice in 3 months prior to screening (determined by urine continine < 500 ng/mL, at Screening visit)
• Males and non-pregnant, non-breastfeeding females
• Males who are sexually active with women of childbearing potential must agree to follow a highly effective method(s) of contraception for the duration of treatment with study drug as well as for an additional 90 days post-treatment completion. Women of childbearing potential who are sexually active with a fertile male must agree to follow instructions for double methods of contraception for the duration of their participation in the trial and for 90 days post-treatment completion
• Documented diagnosis of mild asthma
• 18 to 55 years of age
• Lung function ≥ 70% predicted for FEV1 and FEV1/FVC ratio ≥ 0.7
• FeNO ≥ 35 ppb at Screening and during pre-qualification for the study

Exclusion Criteria:

• History or clinical manifestations of any clinically significant medical disorder that, in the opinion of the investigator, may put the subject at risk because of participation in the study, influence the results of the study, or affect the subject's ability to participate in the study

• A history of drug or alcohol abuse

• History of, or known significant infection including hepatitis A, B, or C, Human immunodeficiency Virus (HIV), tuberculosis (i.e., positive result for interferon [IFN]-γ release assay [IGRA], QuantiFERON® TB-Gold), that may put the subject at risk during participation in the study

• History of cancer within the last 10 years (20 years for breast cancer) except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured. Any history of lymphoma is not allowed

• Any clinically significant illness, infection, medical/surgical procedure, or trauma within 4 weeks of Day 1 or planned inpatient surgery or hospitalization during the study period

• Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, as judged by the Principal Investigator

• Significant history of recurrent ongoing 'dry eye syndrome' of any cause that may be chronic or acute, that may affect the interpretation of safety data associated with the potential for ADAs targeted to PRS-060 (structurally related to tear lipocalin)

• Subjects who have received live or attenuated vaccine in the 4 weeks prior to Day 1

• Subjects with a disease history suggesting abnormal immune function

• History of anaphylaxis following any biologic therapy and known history of allergy or reaction to any component of the investigational product formulation

• Inability to communicate well with the Investigator (i.e., language problem, poor mental development, or impaired cerebral function)

• Participation in any clinical study for a New Chemical Entity within the previous 16 weeks or a marketed drug clinical study within the previous 12 weeks or within 5 half-lives, whichever is the longer, before the first dose of study drug

• Donation of 450 mL or more blood within the previous 12 weeks

• Women who are pregnant, or breastfeeding, or planning to become pregnant within the study period or 90 days post-treatment completion

• Males who are sexually active with a female partner of childbearing potential and who have not had a vasectomy and who do not agree to a highly effective method of contraception from Day 1 to 90 days post-treatment completion. Females of childbearing potential who are sexually active with a fertile male partner who do not agree to double methods of contraception with at least one barrier from Day 1 to 90 days post-treatment completion

• Life-threatening asthmatic episode in the past

• C-reactive protein (CRP) above 5 mg/L

• Use of the following medicines within the specified time before screening:

  • Long-acting β2 agonists; none for 4 weeks prior to Screening
  • Anti-IgE or anti-IL-5 therapy; for 6 months prior to Screening
  • Inhaled corticosteroids (> 500 μg per day of beclometasone dipropionate [BDP] or equivalent) within 16 weeks prior to Screening
  • Inhaled corticosteroids; none for 4 weeks prior to screening
  • Oral or injectable steroids for the treatment of asthma or respiratory tract infection within 5 years prior to Screening
  • Intranasal steroids within 4 weeks prior to Screening
  • Topical steroids within 4 weeks prior to Screening
  • Leukotriene antagonists within 2 weeks prior to Screening
  • Xanthines (excluding caffeine), anticholinergics, or cromoglycate within 1 week prior to Screening
  • PRS-060 at anytime