Healthy VolunteersPhase 1NCT06048887
Single and Multiple-Ascending Dose Study of CRN04894 in Healthy Volunteers
A Phase 1 study testing CRN04894 Oral Solution in people with Healthy Volunteers, run by Crinetics Pharmaceuticals Inc. at 1 site in United States.
Trial summary
A Phase 1, first-in-human, double-blind, randomized, placebo-controlled study to evaluate the safety of CRN04894 in healthy volunteers as well as the relationship between exposure and pharmacodynamic (PD) parameters. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- CRN04894 Oral Solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2020to 11 Apr 2022
- 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
- Females must be either postmenopausal or surgically sterile; or using stable and permitted highly effective method of contraception - use of oral hormonal contraceptives are not allowed during the study
- Male subjects must be surgically sterile or agree to use highly effective form of contraception when sexually active with a female partner of child bearing potential
- ACTH-stimulated serum cortisol high-dose ACTH stimulation test conducted at Screening
Who cannot join
- Use of topical, nasal, inhaled, or oral corticosteroids.
- Use of any investigational drug within the past 60 days.
- Have a medically significant illness within 30 days prior to screening.
- Use of prohibited prescribed or nonprescribed medications and/or nonmedications/alternative medicinal products.
- Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study.
- Unstable psychological disorder ≤1 year prior to Screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CRN04894 in Healthy Volunteers
A Phase 1, first-in-human, double-blind, randomized, placebo-controlled study to evaluate the safety of CRN04894 in healthy volunteers as well as the relationship between exposure and pharmacodynamic (PD) parameters.
- Conditions
- Healthy Volunteers
- Being tested
- CRN04894 Oral Solution, Placebo Oral Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRN04894 Oral SolutionDrug
CRN04894 is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) antagonist.
Placebo Oral SolutionDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose (Part 1) | Experimental | Not described Receives: Drug: CRN04894 Oral Solution; Drug: Placebo Oral Solution |
| Multiple Ascending Dose (Part 2) | Experimental | Not described Receives: Drug: CRN04894 Oral Solution; Drug: Placebo Oral Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with treatment-emergent adverse events
Measured: Part 1 - up to Day 8; Part 2 - up to Day 20
Proportion of participants with a clinically significant safety laboratory observation
Measured: Part 1 - up to Day 8; Part 2 - up to Day 20
Secondary outcomes (4)
Pharmacokinetics (AUC)
Assessment of the plasma area under the curve of CRN04894
Measured: Part 1 - up to Day 8; Part 2 - up to Day 20
Pharmacokinetics (Cmax)
Assessment of the maximum observed plasma concentration of CRN04894
Measured: Part 1 - up to Day 8; Part 2 - up to Day 20
Pharmacokinetics (Tmax)
Assessment of time to maximal CRN04894 concentration (Tmax)
Measured: Part 1 - up to Day 8; Part 2 - up to Day 20
Pharmacokinetics (T1/2)
Assessment of elimination half-life of CRN04894
Measured: Part 1 - up to Day 8; Part 2 - up to Day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start18 Dec 2020
- Primary completion11 Apr 2022
- Study completion11 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crinetics Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048887
- Sponsor's protocol ID
- CRN04894-01
- Status last verified
- Sep 2023
- First submitted
- 11 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CRN04894 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06048887
- Acronym / sponsor ID
- CRN04894-01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Crinetics Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 21 Sep 2023 (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.
A Phase 1, first-in-human, double-blind, randomized, placebo-controlled study to evaluate the safety of CRN04894 in healthy volunteers as well as the relationship between exposure and pharmacodynamic (PD) parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose (Part 1) | Experimental | Drug: CRN04894 Oral Solution, Drug: Placebo Oral Solution |
| Multiple Ascending Dose (Part 2) | Experimental | Drug: CRN04894 Oral Solution, Drug: Placebo Oral Solution |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Females must be either postmenopausal or surgically sterile; or using stable and permitted highly effective method of contraception - use of oral hormonal contraceptives are not allowed during the study
- Male subjects must be surgically sterile or agree to use highly effective form of contraception when sexually active with a female partner of child bearing potential
- ACTH-stimulated serum cortisol high-dose ACTH stimulation test conducted at Screening
Key exclusion criteria (6 listed)
- Use of topical, nasal, inhaled, or oral corticosteroids.
- Use of any investigational drug within the past 60 days.
- Have a medically significant illness within 30 days prior to screening.
- Use of prohibited prescribed or nonprescribed medications and/or nonmedications/alternative medicinal products.
- Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study.
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 |
|---|---|---|
| CRN04894 Oral SolutionCRN04894 is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) antagonist. | Drug | Multiple Ascending Dose (Part 2), Single Ascending Dose (Part 1) |
| Placebo Oral SolutionPlacebo | Drug | Multiple Ascending Dose (Part 2), Single Ascending Dose (Part 1) |
Primary outcome
Percentage of subjects with treatment-emergent adverse events
Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20
Proportion of participants with a clinically significant safety laboratory observation
Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20
4 secondary outcomes
Pharmacokinetics (AUC)
Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20
Pharmacokinetics (Cmax)
Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20
Pharmacokinetics (Tmax)
Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20
Pharmacokinetics (T1/2)
Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20
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 21 Sep 2023.
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Screening Protocol
Pain
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 CRN04894 Oral Solution in people with Healthy Volunteers, run by Crinetics Pharmaceuticals 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 3 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: finished, as of the sponsor's last update on 21 Sep 2023. 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. 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?
Percentage of subjects with treatment-emergent adverse events (time frame: Part 1 - up to Day 8; Part 2 - up to Day 20). 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 21 Sep 2023.