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バイキング・セラピューティクスPhase 1 Study to Evaluate the Safety and Tolerability of VK2735 第I相・フェーズ1 92 無作為化 二重盲検 プラセボ対照
Part A (Single Ascending Dose \[SAD\]) will be conducted to assess the safety, tolerability, and PK profile in healthy participants following 1 single SC injection of VK2735 or VK2735 matching placebo (SAD Cohort 1 through SAD Cohort 6).
Part B (Multiple Ascending Dose \[MAD\]) will be conducted to assess the safety, tolerability, PK and PD profile in otherwise healthy participants who...
もっと見るA Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VK2735, a Dual Glucagon-like Peptide-1 and Gastric Inhibitory Polypeptide Receptor Agonist, in Healthy Adults and Otherwise Healthy Adults Who Have an Increased Body Mass Index
- VK2735-101
| 参加グループ/群 | 介入/治療法 |
|---|---|
プラセボ対照薬Placebo (Part A) Placebo administered SC once in healthy participants | プラセボ Administered SC |
実験的VK2735 (Part A) Escalating doses of VK2735 administered subcutaneously (SC) once in healthy participants. | VK2735 Administered SC |
プラセボ対照薬Placebo (Part B) Placebo administered SC once weekly for four weeks in healthy participants | プラセボ Administered SC |
実験的VK2735 (Part B) Escalating doses of VK2735 administered subcutaneously (SC) once weekly in healthy participants. | VK2735 Administered SC |
プラセボ対照薬VK2735 (Part C ) Placebo administered orally daily for 28 days in healthy participants | VK2735 Placebo Administered orally |
実験的VK2735 (Part C) Escalating doses of VK2735 administered daily (PO) in healthy participants. | VK2735 Drug Administered orally |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious AEs (TESAEs) | To evaluate the safety and tolerability of single doses of subcutaneous injections of VK2735 in healthy participants | 8 days |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Evaluate the Pharmacokinetic profile of VK2735 | Pharmacokinetic profile of VK2735 by measuring peak plasma concentration (Cmax) | 29 days |
Participants must be capable of giving signed informed consent
Participants must be medically healthy, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening and/or before administration of the initial dose of IP in the opinion of the Investigator
Participant body weight must have been stable (no change greater than 5%) for a minimum 8 weeks prior to Screening
Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other clinical study procedures
Willing to comply with contraception requirements
Any surgical or medical condition (active or chronic) that may interfere with IP distribution, metabolism, excretion, or drug absorption
Participants may be excluded from the study if they have conditions that might compromise safety or other endpoints in the study as judged by the Sponsor (or designee) or Investigator
History or presence of clinically significant acute or unstable cerebrovascular (stroke), hepatic, renal, gastrointestinal, pulmonary, immunological, endocrine, diabetes, hematological, oncological, or central nervous disorder that in the opinion of the Investigator would pose a significant risk for the participant
Use of any investigational drug or product, or participation in an investigational drug study within 30 days prior to dosing or 5 half-lives of the drug (whichever is longest)
Active smoker and/or user of nicotine-containing products unless the participant agrees to discontinue smoking/use of nicotine-containing products from 2 weeks before first IP dose administration through to study completion, including the Follow-up period
Have serum triglycerides > 5.65 mmol/L (500 mg/dL) at Screening
Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or HIV
バイキング・セラピューティクスSouth Australia