Testing CG001419 in healthy volunteers for pain management

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 study is testing a new pain management drug called CG001419 in healthy volunteers to see how safe it is and how much of it works best before it’s used for people in pain.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Cullgen Australia Pty Ltd (industry)
• Locations: 1 site (Adelaide, South Australia)
• Trial ID: NCT06636500 on ClinicalTrials.gov

What this trial studies

This is a Phase 1 dose-finding study evaluating the safety and tolerability of CG001419 administered orally to healthy volunteers. Participants will receive either a single dose or multiple doses of the drug, with or without food, to determine the optimal dosing regimen. The ultimate goal is to develop CG001419 for future use in patients suffering from pain. The study will assess various health parameters to ensure participant safety throughout the trial.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18-65 with a BMI between 18-32 kg/m2.

Not a fit: Patients with significant health issues or outside the specified age and BMI range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to the development of a new pain management medication for patients.

How similar studies have performed: While this approach is common in early-phase drug development, the specific drug CG001419 has not been tested in previous studies.

Eligibility criteria

Inclusion Criteria:

* 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:

  1. Refrain from donating sperm

     AND, either:
  2. 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
  3. 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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  1. 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
  2. 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).

Exclusion Criteria:

* 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.

Where this trial is running

Adelaide, South Australia

• CMAX Clinical Research — Adelaide, South Australia, Australia (RECRUITING)

Study contacts

• Study coordinator: Jialiang Wang, PhD

Conditions: Healthy Volunteer Study, Pain Management