Healthy ParticipantsPhase 1NCT07905560
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 Phase 1 study testing SUN-0864 (Formulation 1) or SUN-0864 (Formulation 2) in people with Healthy Participants, run by Superluminal Medicines, Inc..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- SUN-0864 (Formulation 1) or SUN-0864 (Formulation 2)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Feb 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
- Participants with clinically significant abnormalities for laboratory values or physical examination.
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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:
Read more
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.
- Conditions
- Healthy Participants
- Being tested
- SUN-0864 or placebo, SUN-0864 (Formulation 1) or SUN-0864 (Formulation 2), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUN-0864 or placeboDrug
Single ascending dose of SUN-0864 or placebo (oral)
SUN-0864 or placeboDrug
Multiple ascending dose of SUN-0864 or placebo (oral)
SUN-0864 or placeboDrug
Multiple doses of SUN-0864 or placebo (oral)
SUN-0864 (Formulation 1) or SUN-0864 (Formulation 2)Drug
SUN-0864 (oral) Dose level Formulation 1 (fasted) and Formulation 2 (fasted and fed)
PlaceboDrug
Placebo (oral)
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (SAD) | Experimental | Not described Receives: Drug: SUN-0864 or placebo |
| Part 2 (28-day, MAD) | Experimental | Not described Receives: Drug: SUN-0864 or placebo |
| Part 3 (12-week, multiple doses) | Experimental | Not described Receives: Drug: SUN-0864 or placebo |
| Part 4 (relative bioavailability/Food Effect) | Experimental | Not described Receives: Drug: SUN-0864 (Formulation 1) or SUN-0864 (Formulation 2) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) (Part 1)
Measured: Baseline up to Follow-Up (From Day -28 (Screening) to Day 37 (FUP visit)
Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) (Part 2)
Measured: From Day -28 (Screening) to Day 60 (FUP visit)
Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) (Part 3)
Measured: From Day -28 (Screening) to Day 119 (FUP visit)
Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) (Part 4)
Measured: From Day -28 (Screening) to Day 37 (FUP visit)
Cmax measurement of SUN-0864 in Part 4
Measured: up to 48 hours post-dose. Daily from Day 1 (Predose) to Day 3.
Tmax measurement of SUN-0864 in Part 4
Measured: up to 48 hours post-dose. Daily from Day 1 (Predose) to Day 3.
t1/2 measurement of SUN-0864 in Part 4
Measured: up to 48 hours post-dose. Daily from Day 1 (Predose) to Day 3.
AUClast measurement of SUN-0864 in Part 4
Measured: up to 48 hours post-dose. Daily from Day 1 (Predose) to Day 3.
AUCinf measurement of SUN-0864 in Part 4
Measured: up to 48 hours post-dose. Daily from Day 1 (Predose) to Day 3.
AUC24 measurement of SUN-0864 in Part 4
Measured: up to 24 hours post-dose. Daily from Day 1 (Predose) to Day 3.
Secondary outcomes (5)
Change from Baseline in body weight in Part 3
Measured: Baseline to Follow-up, up to Day 119
Cumulative percentage fraction of the drug Excreted in Urine Over the Dosing Interval (Fe) in Part 2
Measured: Pre-dose to 24 hours post-dose on Day 28
Renal Clearance (CLr) in Part 2
Measured: Pre-dose to 24 hours post-dose on Day 28
Plasma PK parameters Cmax (Part 1)
Measured: up to 48 hours post-dose on Day 1 of each Period (Part 1). Daily from Day 1 (Predose) to Day 3.
Plasma PK parameters Cmax (Part 2)
Measured: 48 hours post-dose on Day 30 (Part 2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Superluminal Medicines, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Benjamin Snyder, Dr, Principal investigator, Veritus Research, VIC, AUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905560
- Sponsor's protocol ID
- SUN-0864-1001
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07905560
- Acronym / sponsor ID
- SUN-0864-1001
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Superluminal Medicines, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1 (SAD) | Experimental | Drug: SUN-0864 or placebo |
| Part 2 (28-day, MAD) | Experimental | Drug: SUN-0864 or placebo |
| Part 3 (12-week, multiple doses) | Experimental | Drug: SUN-0864 or placebo |
| Part 4 (relative bioavailability/Food Effect) | Experimental | Drug: SUN-0864 (Formulation 1) or SUN-0864 (Formulation 2) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
- Participants with clinically significant abnormalities for laboratory values or physical examination.
- History of major depressive disorder or history of other severe psychiatric disorders or any history of suicidal behavior.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUN-0864 or placeboSingle ascending dose of SUN-0864 or placebo (oral) | Drug | Part 1 (SAD) |
| SUN-0864 or placeboMultiple ascending dose of SUN-0864 or placebo (oral) | Drug | Part 2 (28-day, MAD) |
| SUN-0864 or placeboMultiple doses of SUN-0864 or placebo (oral) | Drug | Part 3 (12-week, multiple doses) |
| SUN-0864 (Formulation 1) or SUN-0864 (Formulation 2)SUN-0864 (oral) Dose level Formulation 1 (fasted) and Formulation 2 (fasted and fed) | Drug | Part 4 (relative bioavailability/Food Effect) |
| PlaceboPlacebo (oral) | Drug | Placebo |
Primary outcome
Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) (Part 1)
Time frame: Baseline up to Follow-Up (From Day -28 (Screening) to Day 37 (FUP visit)
Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) (Part 2)
Time frame: From Day -28 (Screening) to Day 60 (FUP visit)
Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) (Part 3)
Time frame: From Day -28 (Screening) to Day 119 (FUP visit)
Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) (Part 4)
Time frame: From Day -28 (Screening) to Day 37 (FUP visit)
Cmax measurement of SUN-0864 in Part 4
Time frame: up to 48 hours post-dose. Daily from Day 1 (Predose) to Day 3.
Tmax measurement of SUN-0864 in Part 4
Time frame: up to 48 hours post-dose. Daily from Day 1 (Predose) to Day 3.
t1/2 measurement of SUN-0864 in Part 4
Time frame: up to 48 hours post-dose. Daily from Day 1 (Predose) to Day 3.
AUClast measurement of SUN-0864 in Part 4
Time frame: up to 48 hours post-dose. Daily from Day 1 (Predose) to Day 3.
AUCinf measurement of SUN-0864 in Part 4
Time frame: up to 48 hours post-dose. Daily from Day 1 (Predose) to Day 3.
AUC24 measurement of SUN-0864 in Part 4
Time frame: up to 24 hours post-dose. Daily from Day 1 (Predose) to Day 3.
5 secondary outcomes
Change from Baseline in body weight in Part 3
Time frame: Baseline to Follow-up, up to Day 119
Cumulative percentage fraction of the drug Excreted in Urine Over the Dosing Interval (Fe) in Part 2
Time frame: Pre-dose to 24 hours post-dose on Day 28
Renal Clearance (CLr) in Part 2
Time frame: Pre-dose to 24 hours post-dose on Day 28
Plasma PK parameters Cmax (Part 1)
Time frame: up to 48 hours post-dose on Day 1 of each Period (Part 1). Daily from Day 1 (Predose) to Day 3.
Plasma PK parameters Cmax (Part 2)
Time frame: 48 hours post-dose on Day 30 (Part 2).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin Snyder, Dr principal investigator
Veritus Research, VIC, AUS
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SUN-0864 (Formulation 1) or SUN-0864 (Formulation 2) in people with Healthy Participants, run by Superluminal Medicines, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jil Sutt (781 786 8484, jill.sutt@superluminalrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) (Part 1) (time frame: Baseline up to Follow-Up (From Day -28 (Screening) to Day 37 (FUP visit)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.