ACTRN12622001572752
Terminated
Phase 1
A Phase 1, Randomized, Blinded, Placebo-Controlled, First-in-Human, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APR002 Administered by Inhalation in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Avance Clinical Pty Ltd
- Enrollment
- 42
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. The participant is a healthy adult male or female. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease following a detailed medical history (specific attention to prior asthma or AR); a complete physical examination; vital signs; blood sampling of hematology, chemistry, and virology; urinalysis, and urine drug testing. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy participants.
- •2\. The participant is aged 18 to 55 years, inclusive at the time of consent.
- •3\. The participant weighs at least 45 kg (99 lb) and has a body mass index (BMI) between 18\.0 and 32\.0 kg/m2, inclusive at Screening.
- •4\. A male participant who is nonsterilized and sexually active with a female partner of
- •childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 90 days after the dose of study drug.
- •5\. A female participant of childbearing potential\* who is sexually active with a nonsterilized male partner agrees to use adequate contraception from the time of signing the informed consent, throughout the duration of the study, and for 30 days after the dose of study drug.
- •\*Females of non\-childbearing potential may be enrolled. Female participants of childbearing potential must follow protocol specified contraception guidance.
- •6\. Continuous non\-smoker who has not used tobacco/nicotine\-containing products for at
- •least 3 months prior to the first dosing based on participant self\-reporting.
- •7\. Medically healthy (i.e., with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the Investigator or designee), including according to the following:
Exclusion Criteria
- •1\. Is mentally or legally incapacitated or has significant emotional problems at the time of the Screening Visit or expected during the conduct of the study.
- •2\. History or presence of clinically significant medical (e.g., chronic obstructive pulmonary disease, asthma, COVID\-19, etc.) or psychiatric condition or disease in the opinion of the Investigator or designee. For example, pulmonary function test results should
- •be within normal range, FEV1 % Predicted: 80 to 120%, FVC % Predicted: 80 to 120%, FEV1/FVC % Predicted: 85 to 110%.
- •3\. History of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
- •4\. History of unexplained syncope.
- •5\. History or presence of acute porphyria at the Screening Visit.
- •6\. Lymphoma, leukemia, or any malignancy within the past 5 years of the Screening Visit except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years or breast cancer within the past
- •10 years of the Screening Visit.
- •7\. Clinically significant cardiac disease (e.g., myocardial infarction, stroke, unstable angina, claudication) within 6 months prior to check\-in.
- •8\. History of clinically significant hepatic impairment.
Outcomes
Primary Outcomes
Not specified
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