Healthy Volunteer StudyPhase 1NCT06636500
A Phase 1 Study of CG001419 Administered Orally in Healthy Subjects
A Phase 1 study testing CG001419 in people with Healthy Volunteer Study and Pain Management, run by Cullgen Australia Pty Ltd at 1 site in Australia.
Trial summary
This is a dose finding study of CG001419, administered as a single dose, with or without food, and as multiple doses. CG001419 is being tested in healthy volunteers in this trial with the goal of eventually developing the drug for patients with pain if it is found to be safe and well tolerated. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Study, Pain Management
- What is being tested?
- CG001419
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteAustralia
- Study dates
- 22 Jan 2025to 5 Dec 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cis-male and cis-female subjects must be 18-65 years, inclusive, at the time of signing the informed consent form (ICF).
- Subjects who are in good general health according to the judgment of the investigator per local guidance, eg, with no clinically relevant abnormalities based on medical history, physical examinations, neurological examinations, clinical laboratory evaluations (hematology and clinical chemistry), vital signs, and 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, would affect subject safety.
- Subjects who have a body mass index (BMI) of 18-32 kg/m2 (inclusive) at screening.
- Male subjects are eligible to participate if they are permanently sterile by vasectomy (at least 6 months), or agree to the following during the study and for at least 90 days after the last dose of study drug:
- Refrain from donating sperm
- AND, either:
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- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR
- Agree to use a male condom (contraception/barrier) and should also be advised of the benefit for a female partner to use an acceptable, highly effective method of contraception (of low user dependency or is user dependent), as a condom may break or leak when having sexual intercourse 5. Female subjects are eligible to participate if they are not pregnant or breastfeeding and fall under 1 of the following criteria:
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- Women of childbearing potential (WOCBP), defined as women physiologically capable of becoming pregnant, must have a negative serum pregnancy test at the Screening visit and a negative urine pregnancy test on Day -1; WOCBP must agree to be abstinent from heterosexual intercourse or use an acceptable, highly effective contraceptive method (of low user dependency or is user dependent) from Screening and not donate eggs until 30 days after the last dose of the study drug.
- OR
- Menopausal women must have an elevated serum follicle-stimulating hormone level (FSH >40 IU/mL) level at Screening; if the FSH is not elevated, they are considered to be of childbearing potential (unless permanently sterile).
Who cannot join
- Clinically significant infection and/or cardiovascular, hematological, renal, hepatic, pulmonary (except recovered childhood asthma), endocrine, reproductive, gastrointestinal, immunological, dermatological, neurological (except migraine), or psychiatric (except depression, which was potentially medicated in the past but didn't require hospitalization) diseases, which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the investigator, unacceptably increase the subject's risk if he/she were to participate in the study.
- History of neuropathy and/or any neurosensory symptoms in the feet or hands.
- Unable to ingest a high-fat meal, such as those who are lactose intolerant (only for subjects in the FE part and if recommended, MAD part too)
- History of disorders that affect gastrointestinal transit time (eg, short bowel syndrome, gastroparesis, irritable bowel syndrome, inflammatory bowel diseases, history of gastric bypass
- Use of prescription drugs, over-the-counter drugs (other than acetaminophen and ibuprofen), herbal medications, or vitamin supplements within 7 days or 5 half-lives, whichever is longer, prior to dosing and antibiotics and systemic steroids within 30 days prior to dosing. Oral contraceptives are permitted. The sponsor, after consulting medical monitor may allow exceptions only if the medication's administration is deemed unlikely to impact the PK results.
- Past or current history or evidence of drug or alcohol abuse, alcohol consumption exceeding 5 units of alcohol on an average per day (1 unit of alcohol = 150 mL of wine, 360 mL of beer, or 45 mL of alcohol 40%). Use of any non-marijuana illicit drugs (e.g., cocaine, phencyclidine) within 6 months of Screening.
- Donation of over 500 mL of blood within 8 weeks prior to Screening.
- In the opinion of the investigator the subject is unlikely to comply with the study procedures, restrictions, and requirements and is not suitable for entry into the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single and Multiple Ascending Dose and Food Effect Study of CG001419 Administered Orally to Evaluate Safety, Tolerability and Pharmacokinetics in Healthy Subjects
This is a dose finding study of CG001419, administered as a single dose, with or without food, and as multiple doses. CG001419 is being tested in healthy volunteers in this trial with the goal of eventually developing the drug for patients with pain if it is found to be safe and well tolerated.
- Conditions
- Healthy Volunteer Study, Pain Management
- Being tested
- CG001419, Placebo
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CG001419Drug
Oral doses
PlaceboDrug
Oral doses
| Study group | Role | What they receive |
|---|---|---|
| CG001419 | Experimental | Part A: Single ascending dose cohorts; food effect cohort; Part B: Multiple ascending dose cohorts Receives: Drug: CG001419 |
| Placebo | Placebo comparator | Part A: Single ascending dose cohorts; Part B: Multiple ascending dose cohorts Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of single and multiple ascending oral doses of CG001419 in healthy subjects
Safety and tolerability based on adverse events (AEs)
Measured: Up to 7 days of dosing
Secondary outcomes (8)
To further characterize the PK of CG001419 in healthy subjects
Cmax
Measured: Up to 7 days of dosing
To further characterize the PK of CG001419 in healthy subjects
Tmax
Measured: Up to 7 days of dosing
To further characterize the PK of CG001419 in healthy subjects
Area under the concentration curve from 0 to last (AUC0-last)
Measured: Up to 7 days of dosing
To further characterize the PK of CG001419 in healthy subjects
Area under the concentration curve from 0 to infinity (AUC0-inf)
Measured: Up to 7 days of dosing
To further characterize the PK of CG001419 in healthy subjects
Elimination rate constant (λz)
Measured: Up to 7 days of dosing
To further characterize the PK of CG001419 in healthy subjects
Terminal elimination half-life (t1⁄2)
Measured: Up to 7 days of dosing
To further characterize the PK of CG001419 in healthy subjects
Apparent oral clearance (CL/F)
Measured: Up to 7 days of dosing
To further characterize the PK of CG001419 in healthy subjects
Apparent volume of distribution (Vd/F)
Measured: Up to 7 days of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start22 Jan 2025
- Primary completion5 Dec 2025
- Study completion5 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteer StudyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo-Controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cullgen Australia Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636500
- Sponsor's protocol ID
- CG001419-101
- Status last verified
- Feb 2026
- First submitted
- 8 Oct 2024
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a healthy volunteer study being conducted to define the safety profile of the drug. This study is not exploring the activity of our drug in the target indication population (patients with pain). As such, we do not believe there is utility for sharing deidentified IPD from this trial with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single and Multiple Ascending Dose and Food Effect Study of CG001419 Administered Orally to Evaluate Safety, Tolerability and Pharmacokinetics in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06636500
- Acronym / sponsor ID
- CG001419-101
- Conditions
- Healthy Volunteer Study, Pain Management
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Cullgen Australia Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 5 Dec 2025 (actual)
- Study completion
- 5 Dec 2025 (actual)
- First posted
- 10 Oct 2024 (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 dose finding study of CG001419, administered as a single dose, with or without food, and as multiple doses. CG001419 is being tested in healthy volunteers in this trial with the goal of eventually developing the drug for patients with pain if it is found to be safe and well tolerated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo-Controlled
| Arm | Type | Receives |
|---|---|---|
| CG001419 | Experimental | Drug: CG001419Part A: Single ascending dose cohorts; food effect cohort; Part B: Multiple ascending dose cohorts |
| Placebo | Placebo comparator | Drug: PlaceboPart A: Single ascending dose cohorts; Part B: Multiple ascending dose cohorts |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Cis-male and cis-female subjects must be 18-65 years, inclusive, at the time of signing the informed consent form (ICF).
- Subjects who are in good general health according to the judgment of the investigator per local guidance, eg, with no clinically relevant abnormalities based on medical history, physical examinations, neurological examinations, clinical laboratory evaluations (hematology and clinical chemistry), vital signs, and 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, would affect subject safety.
- Subjects who have a body mass index (BMI) of 18-32 kg/m2 (inclusive) at screening.
- Male subjects are eligible to participate if they are permanently sterile by vasectomy (at least 6 months), or agree to the following during the study and for at least 90 days after the last dose of study drug:
- <!-- -->
Key exclusion criteria (8 listed)
- Clinically significant infection and/or cardiovascular, hematological, renal, hepatic, pulmonary (except recovered childhood asthma), endocrine, reproductive, gastrointestinal, immunological, dermatological, neurological (except migraine), or psychiatric (except depression, which was potentially medicated in the past but didn't require hospitalization) diseases, which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the investigator, unacceptably increase the subject's risk if he/she were to participate in the study.
- History of neuropathy and/or any neurosensory symptoms in the feet or hands.
- Unable to ingest a high-fat meal, such as those who are lactose intolerant (only for subjects in the FE part and if recommended, MAD part too)
- History of disorders that affect gastrointestinal transit time (eg, short bowel syndrome, gastroparesis, irritable bowel syndrome, inflammatory bowel diseases, history of gastric bypass
- Use of prescription drugs, over-the-counter drugs (other than acetaminophen and ibuprofen), herbal medications, or vitamin supplements within 7 days or 5 half-lives, whichever is longer, prior to dosing and antibiotics and systemic steroids within 30 days prior to dosing. Oral contraceptives are permitted. The sponsor, after consulting medical monitor may allow exceptions only if the medication's administration is deemed unlikely to impact the PK results.
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 |
|---|---|---|
| CG001419Oral doses | Drug | CG001419 |
| PlaceboOral doses | Drug | Placebo |
Primary outcome
To evaluate the safety and tolerability of single and multiple ascending oral doses of CG001419 in healthy subjects
Time frame: Up to 7 days of dosing
Safety and tolerability based on adverse events (AEs)
8 secondary outcomes
To further characterize the PK of CG001419 in healthy subjects
Time frame: Up to 7 days of dosing
To further characterize the PK of CG001419 in healthy subjects
Time frame: Up to 7 days of dosing
To further characterize the PK of CG001419 in healthy subjects
Time frame: Up to 7 days of dosing
To further characterize the PK of CG001419 in healthy subjects
Time frame: Up to 7 days of dosing
To further characterize the PK of CG001419 in healthy subjects
Time frame: Up to 7 days of dosing
To further characterize the PK of CG001419 in healthy subjects
Time frame: Up to 7 days of dosing
To further characterize the PK of CG001419 in healthy subjects
Time frame: Up to 7 days of dosing
To further characterize the PK of CG001419 in healthy subjects
Time frame: Up to 7 days of dosing
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 20 Feb 2026.
- Individual participant dataSharing planned: No. This is a healthy volunteer study being conducted to define the safety profile of the drug. This study is not exploring the activity of our drug in the target indication population (patients with pain). As such, we do not believe there is utility for sharing deidentified IPD from this trial with other researchers.
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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 CG001419 in people with Healthy Volunteer Study and Pain Management, run by Cullgen Australia Pty Ltd at 1 site in Australia.
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 12 inclusion and 8 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 20 Feb 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 Australia. 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?
To evaluate the safety and tolerability of single and multiple ascending oral doses of CG001419 in healthy subjects (time frame: Up to 7 days of dosing). 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 20 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.