A Randomised, Double-blind, Placebo-controlled, Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Subcutaneous, Ascending Single Doses of AP13 in Healthy Adults
Apollo Therapeutics
39 participants
Feb 27, 2024
Interventional
Conditions
Summary
This is a first-in-human, single-centre, randomised, double blind, ascending single dose study to assess the safety and tolerability of AP13 and how this drug acts in the body in healthy volunteers. AP13 may be indicated for use in patients with pulmonary hypertension, but a trial of the drug in healthy volunteers is needed before trials in patients with pulmonary hypertension can proceed. Who is it for? You may be eligible for this study if you are aged 18 to 55 years and are in good general health without a clinically significant medical history. Study details: All healthy volunteer participants who choose to enrol in this study will be assigned by chance to receive either a single dose of AP13 or placebo. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. The data generated in this study will inform the design of future clinical studies and to select the dose(s) for future studies in patients with pulmonary hypertension.
Eligibility
Inclusion Criteria7
- Healthy adult males and females, 18 to 55 years of age (inclusive) at screening.
- 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.
- 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 Criteria10
- 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.
- History of surgery or hospitalisation within 3 months prior to screening, or surgery planned during the study.
- Any history of malignant disease in the last 10 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
- Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.
- Positive test results for active human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit.
- Positive drugs of abuse test or alcohol breath test results at the screening visit or on admission to the clinic on Day -1.
- Females who are breastfeeding or planning to breastfeed during the study.
- 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.
- 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.
- 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.
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Interventions
This is a randomised, double-blind, placebo-controlled study of AP13 administered subcutaneously (SC) as a single dose. The study will be conducted in 1 part involving a Single ascending dose (SAD) which will comprise of up to 5 cohorts. Each cohort will enrol 8 participants, with 6 randomised to receive a single dose of AP13 and 2 to receive placebo on Day 1 with a dose range of 0.3 - 12 mg/kg. Cohorts will be dosed in an escalating order with participants only able to enrol in one dose cohort. Adherence to the intervention will be done via supervised drug administration.
Locations(2)
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ACTRN12624000086561