Phase I Single-Administration Study of TRG035 in Healthy Adults

JRCT ID: jRCT2051240154

Registered date:08/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: congenital anodontia
• Date of first enrollment: 18/10/2024
• Target sample size: 30
• Study type: Interventional

Intervention(s)

One single intravenous dose of the study drug is administered.
Step 1 (0.4 mg/kg): Single dose of study drug (TRG035 or placebo)
Step 2 (1.2 mg/kg): Single dose of study drug (TRG035 or placebo)
Step 3 (4.0 mg/kg): Single dose of study drug (TRG035 or placebo)
Step 4 (12.0 mg/kg): Single dose of study drug (TRG035 or placebo)
Step 5 (24.0 mg/kg): Single dose of study drug (TRG035 or placebo)

Outcome(s)

• Primary Outcome: Safety
• Secondary Outcome: Pharmacokinetics, frequency of serum anti-TRG035 antibody

Key inclusion & exclusion criteria

• Age minimum: >= 30age old
• Age maximum: < 65age old

Include criteria

1) Males between the ages of 30 and 65 years at the time of obtaining consent
2) BMI between 18.5 kg/m2 and 25.0 kg/m2 at the time of screening test
3) Weight between 40 kg and less than 80 kg at the time of screening examination
4) Missing or missing one or more molars (back teeth)
5) The patient's written consent to participate in this study has been obtained.

Exclude criteria

1) Patients with a current or previous history of hepatic, renal, cardiac or other circulatory, respiratory, gastrointestinal, hematological, malignant tumor, or autoimmune disease that would make them unsuitable for participation in this clinical trial.
2) Patients with a history of epileptic seizures or organic brain disorders that may induce epileptic seizures.
3) Patients who have or have had allergic symptoms or a specific constitution to food, drugs, or metals.
4) Patients with a history of hypersensitivity or allergy to any of the ingredients contained in this product or to antibody products (pharmaceuticals or investigational drugs) administered in the past
5) Patients who are or have been alcohol or drug dependent
6) Patients with a QTc greater than 450 ms on the standard 12-lead electrocardiogram at the screening test.
7) Patients with implants in the molar region
8) Patients whose clinical examination (hematology, blood biochemistry, infectious disease test, and urinalysis) is judged to have clinically significant abnormalities by the investigator (subinvestigator)
9) Patients who have participated in other clinical trials and received an investigational drug or study drug within 16 weeks prior to the start of administration of the investigational drug
10) Received or used any drug (prescription or over-the-counter drug) within 1 week prior to the start of administration of the investigational drug. (However, topical antiseptics, eye drops, etc. that are considered to have no impact on the pharmacokinetics or safety of the investigational drug if used, such as no systemic exposure, are acceptable.
11) Patients who have donated 400 mL or more of blood within 12 weeks prior to the start of treatment with the investigational drug, or who have donated component blood or 200 mL or more of blood within 4 weeks prior to the start of treatment with the investigational drug.
12) Patients with a history of infection within 1 week prior to the start of treatment with the investigational drug, or patients with apparent infection at the time of examination on the day prior to the start of treatment with the investigational drug, who are judged to be inappropriate by the investigator (subinvestigator).
13) Patients who have received a live vaccine within 4 weeks prior to the start of administration of the investigational drug or are scheduled to receive a live vaccine during the study period (by the day of visit 57 after administration of the investigational drug)
14) Patients who received an inactivated vaccine within 1 week prior to the start of this investigational drug or who are scheduled to receive an inactivated vaccine during the study period (from the administration of the investigational drug to the 57th day of visit)
15) Patients who do not intend to use contraception during the study period
16) Other subjects who are judged to be ineligible for the study by the investigator (subinvestigator).

Related Information

• Primary Sponsor: Nakajima Takako
• Source(s) of Monetary Support: Toregem Biopharma