NCT07905560Not yet recruitingPhase 1
A Study of Safety of SUN-0864 and How it is Processed by and Affects the Body in Healthy Adults and Healthy Adults Who Are Overweight or Obese.
A First-In-Human, Randomised, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose and Limited Duration Treatment, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SUN-0864 in Healthy Adult Participants and Participants Who Are Overweight and/or Obese, Otherwise Healthy
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
This Phase 1, first-in-human study will evaluate the safety and tolerability of SUN-0864, how the body processes SUN-0864, and how SUN-0864 affects the body in healthy adults and otherwise healthy adults who are overweight or obese. The study includes four parts: Part 1, a single ascending dose (SAD) assessment in healthy adults; Part 2, a 28-day multiple ascending dose (MAD) assessment in overweight or obese adults; Part 3, a 12-week multiple-dose assessment in overweight or obese adults; and Part 4, an assessment comparing two formulations and evaluating the effect of food on SUN-0864 in healthy adults. Approximately 128 to 138 subjects will be randomized into this study. Dose escalation and selection of dose levels for later study parts will be guided by review of safety, tolerability, and available study data by a Safety Review Committee.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 138 (estimated)
- First submitted
- 23 Oct 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- Superluminal Medicines, Inc.
- Diseases
- Obesity
- NCT number
- NCT07905560
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 138
- From 1 Nov 2026 to the primary completion date, 31 Jan 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, respiratory, dermatologic, inflammatory, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- Any condition possibly affecting drug absorption.
- History of recent surgery requiring general anesthesia (within 12 weeks of Screening)
- History of major depressive disorder or history of other severe psychiatric disorders or any history of suicidal behavior.
- Part 3: any form of diabetes (except gestational diabetes) requiring pharmacologic management and/or on medication to treat hyperglycaemia.
Lab values
- Participants with clinically significant abnormalities for laboratory values or physical examination.
Who the study is looking for
- Healthy male or female subjects between the ages of 18-64 years.
- Part 1 \& 4 Body Mass Index (BMI): 18.0 to 32.0kg/m2; and a total body weight\> 50 kg (110lbs)
- Part 2 BMI: ≥ 27.0 kg/m2 and ≤ 40.0 kg/m2 and a body weight ≥ 70 kg and ≤ 150 kg
- Part 3 BMI: BMI ≥ 30.0 kg/m2 and a body weight ≥ 70 kg
Age in the registry: 18 years to 64 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.