A Randomised, Double-blind, Placebo-controlled, Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Subcutaneous, Ascending Single and Multiple Doses of AP13 in Healthy Adults

Phase 1

Recruiting

• Conditions: Pulmonary Hypertension; Cardiovascular - Hypertension

• Registration Number: ACTRN12624000086561
• Lead Sponsor: Apollo Therapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-31
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1.Healthy adult males and females, 18 to 55 years of age (inclusive) at screening.
2.Body mass index (BMI) greater than or equal to 18.0 and less than or equal to 30.0 kg/m2, with a body weight 50 to 100 kg at screening.
3.Is medically healthy (in the opinion of the PI [or delegate]), as determined by pre-study medical history, and without clinically significant abnormalities including:
a.Physical examination without any clinically relevant findings.
b.Systolic blood pressure in the range of 90 to 140 mmHg and diastolic blood pressure in the range of 40 to 90 mmHg after 5 minutes in semi-supine position.
c.Heart rate in the range of 40 to 90 bpm after 5 minutes rest in semi-supine position.
d.Body temperature (tympanic), between 35.5°C and 37.7°C.

Exclusion Criteria

1.History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric or neurological disease/disorder within the past 3 months, or any acute minor illness (e.g. common cold, influenza, minor infection) within the past 1 month, determined by the PI (or delegate) to be clinically relevant.
2.History of surgery or hospitalisation within 3 months prior to screening, or surgery planned during the study.
3.Any history of malignant disease in the last 10 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
4.Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.
5.Positive test results for active human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit.
6.Positive drugs of abuse test or alcohol breath test results at the screening visit or on admission to the clinic on Day -1.
7.Females who are breastfeeding or planning to breastfeed during the study.
8.Use of any prescription or over-the-counter medication (including herbal products, diet aids, vitamins, and hormone supplements) within 7 days or 5 half-lives of the medication (whichever is longer) prior to the first dose of study drug. Note: use of hormonal contraceptives and the occasional use of paracetamol (up to 2 grams per day) and ibuprofen (up to 1.2 grams per day) is permitted.
9.Donation of blood or plasma within 30 days prior to first dose of study drug, or loss of whole blood of more than 500 mL within 30 days prior to first dose of study drug, or receipt of a blood transfusion within 1 year of the first dose of study drug. Donating blood is permitted only 120 days (5 x AP13 t1/2) following the last dose of study drug.
10.Any other condition or prior therapy that in the opinion of the PI (or delegate) would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.

Study & Design

• Study Type: Interventional
• Study Design: Not specified