PainPhase 1NCT05484414
Safety and Pharmacokinetics of SAD/MAD Oral Doses of SRP-3D (DA)
A Phase 1 study testing SRP-3D (diethylamide) in people with Pain, run by South Rampart Pharma, Inc. at 1 site in United States.
Trial summary
This is a two-part randomized, double-blind, placebo-controlled study. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- SRP-3D (diethylamide)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2021to 6 Nov 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
Who may be able to join
- Healthy male or female. Females must not be pregnant or breastfeeding.
- Is between 18 and 55 years of age (inclusive).
- Able to speak and understand English or Spanish.
- Agrees to comply with testing procedures.
- Has a body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive).
- The subject meets good health criteria.
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- Females of non-childbearing potential or agree to use birth control.
- Male subjects must be surgically sterile or agree to the use birth control.
- Agree to the confinement period and return for the outpatient visits.
- Has vital signs at screening within appropriate ranges.
Who cannot join
- History or presence of clinically significant diseases.
- Abnormal diet 4 weeks preceding the first dose of study medication.
- Received any investigational product in a clinical study.
- Previously been administered IMP in this study.
- Taking any prescribed or OTC drug.
- Taking moderate or strong inhibitors/inducers of cytochrome P450.
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- History of hypersensitivity to acetaminophen or similar chemical entities.
- Presence or history of allergy or blood or plasma donation.
- Blood or plasma donation.
- Smokers and those who have smoked within the last 12 months.
- Current users of e-cigarettes and nicotine replacement products.
- Consumption of prohibited beverages or foods.
- Prior history of substance abuse or treatment.
- Regular alcohol consumption.
- Positive alcohol urine test at screening or admission.
- Is a female with a positive pregnancy test result.
- Positive urine screen for drugs of abuse.
- Positive test for hepatitis B or C, or HIV.
- Active infection, periodontal disease, certain dental appliances.
- Glucose-6-phosphate-dehydrogenase (G6PD) deficiency.
- Significant serious skin disease.
- Cohort 3 only: history of cholecystectomy or gall stones.
- Have poor venous access that limits phlebotomy.
- Evidence of current SARS-CoV-2 infection.
- Clinically significant abnormal clinical chemistry, hematology or urinalysis.
- Immediate family members of a study site or Sponsor employee.
- Failure to satisfy the Investigator of fitness to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-Part Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending and Multiple Ascending Oral Doses of SRP-3D (DA), and to Characterize the Effect of Food on the Pharmacokinetics of SRP-3D (DA), in Healthy Male and Female Subjects
This is a two-part randomized, double-blind, placebo-controlled study.
Read the detailed description
This is a two-part randomized, double-blind, placebo-controlled study. The study comprises a SAD (Part 1) assessment which will include a food effect assessment that contributes data to inform a subsequent MAD (Part 2) dose-ranging study. Safety measurements will be collected throughout the study for all subjects. Blood samples will be collected to determine the PK parameters of SRP-3D (DA).
- Conditions
- Pain
- Being tested
- SRP-3D (diethylamide), Placebo
- Keywords
- Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRP-3D (diethylamide)Drug
Also called SRP-3D (DA)
SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
PlaceboDrug
Also called Control
Matching Placebo for SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL Receives: Drug: SRP-3D (diethylamide) |
| Placebo | Placebo comparator | Matching Placebo for SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL 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-related adverse events as assessed by CTCAE v4.0
Reported AEs
Measured: The time of providing written informed consent until 30 days after the last dose of study drug
Secondary outcomes (10)
PK parameters 1
Lag time (Tlag)
Measured: 6 days
PK parameters 2
Time to reach maximum (peak) plasma concentration following drug administration (Tmax)
Measured: 6 days
PK parameters 3
Maximum (peak) plasma drug concentration (Cmax)
Measured: 6 days
PK parameters 4
Area under the plasma concentration-time curve from time zero to infinity (AUCinf)
Measured: 6 days
PK parameters 5
Area under the plasma concentration-time curve from time zero to infinity (AUClast)
Measured: 6 days
PK parameters 6
Area under the plasma concentration-time curve (AUC0-tau)
Measured: 6 days
PK parameters 7
Terminal disposition rate constant/terminal rate constant (λz)
Measured: 6 days
PK parameters 8
Elimination half-life (T1/2)
Measured: 6 days
PK parameters 9
Apparent total clearance of the drug from plasma after oral administration (CL/F)
Measured: 6 days
PK parameters 10
Apparent volume of distribution during terminal phase after non-intravenous administration (Vz/F)
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start30 Dec 2021
- Primary completion6 Nov 2023
- Study completion6 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Rampart Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hernan A Bazan, MD, Study chair, CEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484414
- Sponsor's protocol ID
- SRP-101
- Status last verified
- Sep 2026
- First submitted
- 27 Jul 2022
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending and Multiple Ascending Oral Doses of SRP-3D (DA), and to Characterize the Effect of Food on the Pharmacokinetics of SRP-3D (DA), in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT05484414
- Acronym / sponsor ID
- SRP-101
- Conditions
- Pain
- Keywords
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- South Rampart Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 6 Nov 2023 (actual)
- Study completion
- 6 Nov 2023 (actual)
- First posted
- 2 Aug 2022 (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 is a two-part randomized, double-blind, placebo-controlled study.
Detailed description
This is a two-part randomized, double-blind, placebo-controlled study. The study comprises a SAD (Part 1) assessment which will include a food effect assessment that contributes data to inform a subsequent MAD (Part 2) dose-ranging study. Safety measurements will be collected throughout the study for all subjects. Blood samples will be collected to determine the PK parameters of SRP-3D (DA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: SRP-3D (diethylamide)SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL |
| Placebo | Placebo comparator | Drug: PlaceboMatching Placebo for SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy male or female. Females must not be pregnant or breastfeeding.
- Is between 18 and 55 years of age (inclusive).
- Able to speak and understand English or Spanish.
- Agrees to comply with testing procedures.
- Has a body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive).
Key exclusion criteria (27 listed)
- History or presence of clinically significant diseases.
- Abnormal diet 4 weeks preceding the first dose of study medication.
- Received any investigational product in a clinical study.
- Previously been administered IMP in this study.
- Taking any prescribed or OTC drug.
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 |
|---|---|---|
| SRP-3D (diethylamide)Also: SRP-3D (DA)SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL | Drug | Experimental |
| PlaceboAlso: ControlMatching Placebo for SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL | Drug | Placebo |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: The time of providing written informed consent until 30 days after the last dose of study drug
Reported AEs
10 secondary outcomes
PK parameters 1
Time frame: 6 days
PK parameters 2
Time frame: 6 days
PK parameters 3
Time frame: 6 days
PK parameters 4
Time frame: 6 days
PK parameters 5
Time frame: 6 days
PK parameters 6
Time frame: 6 days
PK parameters 7
Time frame: 6 days
PK parameters 8
Time frame: 6 days
PK parameters 9
Time frame: 6 days
PK parameters 10
Time frame: 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- 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.
Hernan A Bazan, MD study chair
CEO
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 SRP-3D (diethylamide) in people with Pain, run by South Rampart Pharma, 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?
The sponsor lists 10 inclusion and 27 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: finished, as of the sponsor's last update on 10 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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-related adverse events as assessed by CTCAE v4.0 (time frame: The time of providing written informed consent until 30 days after the last dose of study drug). 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 Sep 2026.