Substance Use DisordersPhase 1NCT06316973
A Clinical Study to Evaluate the Safety of CS-1103 in Healthy Participants
A Phase 1 study testing CS-1103 and Sterile Saline in people with Substance Use Disorders and Methamphetamine Abuse, run by Clear Scientific, Inc. at 1 site in United States.
Trial summary
The purpose of this Phase 1a study is to evaluate safety, tolerability, and pharmacokinetics (PK) of single, ascending doses of CS-1103, administered by intravenous (IV) infusion in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders, Methamphetamine Abuse, Methamphetamine Intoxication
- What is being tested?
- CS-1103 and Sterile Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2024to 6 Jun 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Major Inclusion Criteria:
- Healthy male and/or female participants aged 18 to 55 years, inclusive.
- A body mass index between 18.0 to 30.0 kg/m2, inclusive, and a minimum body weight of 50 kg.
- Females must be of nonchildbearing potential.
Major Exclusion Criteria:
- Estimated glomerular filtration rate <90 mL/min/1.73 m2
- Any clinically significant abnormalities in rhythm, conduction or morphology of the resting ECG, and any clinically important abnormalities in the 12-lead ECG
- Current smokers, or those who have smoked or used nicotine products (including nicotine patches) within 1 month prior to dose administration.
- History of alcohol abuse or excessive intake of alcohol
Trial locations and contacts
1 site in 1 country.
United States1 site
Dr. Vince Clinical Research
Overland Park, Kansas, 66212
About this study
Official title: A Phase 1a, Randomized, Double-Blind, Placebo-Controlled, Single Center Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CS-1103 Following Single, Ascending Intravenous Dose Administration in Healthy Participants
The purpose of this Phase 1a study is to evaluate safety, tolerability, and pharmacokinetics (PK) of single, ascending doses of CS-1103, administered by intravenous (IV) infusion in healthy participants.
- Being tested
- CS-1103, Sterile Saline
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS-1103Drug
CS-1103 for infusion
Sterile SalineDrug
Sterile Saline for Injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 6 participants received a single dose of 2.7 mg/kg (2.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration. Receives: Drug: CS-1103 |
| Cohort 2 | Experimental | 6 participants received single dose of 8.0 mg/kg (7.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration. Receives: Drug: CS-1103 |
| Cohort 3 | Experimental | 6 participants received a single dose of 16.0 mg/kg (15.1 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration. Receives: Drug: CS-1103 |
| Cohort 4 | Experimental | 6 participants received a single dose of 19.0 mg/kg (17.9 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration. Receives: Drug: CS-1103 |
| Placebo | Placebo comparator | 2 participants for each cohort were administered with placebo.
Total administered volume of saline matched administered volume for the corresponding CS-1103 solution in each cohort. Receives: Drug: Sterile Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Treatment-emergent adverse events assessed through physical examinations, vital signs (blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature), electrocardiograms (digital 12-lead electrocardiograms (ECGs). Any correlation between CS-1103 plasma concentrations and changes in QT intervals will be noted), and laboratory parameters (clinical chemistry, hematology, coagulation, and urinalysis).
Measured: 3 days plus 8 days for follow-up
Number of Participants by Severity of AEs
Severity of AEs was classified as mild, moderate, or severe (increasing severity).
A subject experiencing multiple occurrences of an adverse event in a particular category was counted, at most, once for that category for each treatment.
Measured: 3 days plus 8 days for follow-up
Secondary outcomes (6)
Plasma Pharmacokinetic (PK) Parameter: Cmax
Maximum concentration, obtained directly from the observed concentration versus time data.
Measured: End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr
Plasma PK Parameter: Tmax
Time of maximum observed blood plasma concentration (Cmax) of CS-1103
Measured: End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr
Plasma PK Parameter: t1/2
Terminal Elimination Half-life of CS-1103
Measured: End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr
Plasma PK Parameter: CL
Systemic Clearance of CS-1103
Measured: End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr
Plasma PK Parameter: Vz
Volume of Distribution of CS-1103
Measured: End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr
Urine PK Parameter: Fe (0-last)
Cumulative fraction of dose excreted in urine during the pooled collection intervals. Due to inherent error in measuring CS-1103 recovered in urine, the calculated recovery may exceed 100% of the dose.
Measured: Time intervals from 0-24 hours after IV administration of CS-1103
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start7 Feb 2024
- Primary completion30 May 2024
- Study completion6 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Substance Use DisordersStudies 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
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo-Controlled, Single Center Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CS-1103 Following Single, Ascending Intravenous Dose Administration in Healthy Participants
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clear Scientific, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316973
- Sponsor's protocol ID
- CS-1103-01
- Other IDs
- U01DA053054
- Status last verified
- Oct 2025
- First submitted
- 5 Mar 2024
- Last updated
- 10 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a, Randomized, Double-Blind, Placebo-Controlled, Single Center Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CS-1103 Following Single, Ascending Intravenous Dose Administration in Healthy Participants
- ClinicalTrials.gov ID
- NCT06316973
- Acronym / sponsor ID
- CS-1103-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Clear Scientific, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 6 Jun 2024 (actual)
- First posted
- 19 Mar 2024 (actual)
- Results
- Posted 10 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this Phase 1a study is to evaluate safety, tolerability, and pharmacokinetics (PK) of single, ascending doses of CS-1103, administered by intravenous (IV) infusion in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Randomized, Double-Blind, Placebo-Controlled, Single Center Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CS-1103 Following Single, Ascending Intravenous Dose Administration in Healthy Participants
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: CS-11036 participants received a single dose of 2.7 mg/kg (2.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes. A diluted CS-1103 saline solution in an IV bag is used for drug administration. |
| Cohort 2 | Experimental | Drug: CS-11036 participants received single dose of 8.0 mg/kg (7.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes. A diluted CS-1103 saline solution in an IV bag is used for drug administration. |
| Cohort 3 | Experimental | Drug: CS-11036 participants received a single dose of 16.0 mg/kg (15.1 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes. A diluted CS-1103 saline solution in an IV bag is used for drug administration. |
| Cohort 4 | Experimental | Drug: CS-11036 participants received a single dose of 19.0 mg/kg (17.9 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes. A diluted CS-1103 saline solution in an IV bag is used for drug administration. |
| Placebo | Placebo comparator | Drug: Sterile Saline2 participants for each cohort were administered with placebo. Total administered volume of saline matched administered volume for the corresponding CS-1103 solution in each cohort. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| CS-1103CS-1103 for infusion | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| Sterile SalineSterile Saline for Injection | Drug | Placebo |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Time frame: 3 days plus 8 days for follow-up
Treatment-emergent adverse events assessed through physical examinations, vital signs (blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature), electrocardiograms (digital 12-lead electrocardiograms (ECGs). Any correlation between CS-1103 plasma concentrations and changes in QT intervals will be noted), and laboratory parameters (clinical chemistry, hematology, coagulation, and urinalysis).
Number of Participants by Severity of AEs
Time frame: 3 days plus 8 days for follow-up
Severity of AEs was classified as mild, moderate, or severe (increasing severity). A subject experiencing multiple occurrences of an adverse event in a particular category was counted, at most, once for that category for each treatment.
6 secondary outcomes
Plasma Pharmacokinetic (PK) Parameter: Cmax
Time frame: End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr
Plasma PK Parameter: Tmax
Time frame: End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr
Plasma PK Parameter: t1/2
Time frame: End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr
Plasma PK Parameter: CL
Time frame: End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr
Plasma PK Parameter: Vz
Time frame: End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr
Urine PK Parameter: Fe (0-last)
Time frame: Time intervals from 0-24 hours after IV administration of CS-1103
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CS-1103 and Sterile Saline in people with Substance Use Disorders and Methamphetamine Abuse, run by Clear Scientific, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 10 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (AEs) (time frame: 3 days plus 8 days for follow-up). The study lists 2 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 10 Nov 2025; AzTrials last refreshed its copy on 7 Nov 2026.