Single Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of BDM-2 in Healthy Male Subjects.
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Treatment Related Adverse Event, Including Abnormal Laboratory Events |
1; 3; 2; 4; 4; 9 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male aged between 18 and 55 years at screening, inclusive.
- Body Mass Index (BMI) 18.0-32.0 kg/m2 at screening, inclusive.
- Good physical and mental health as established by medical history, physical examination, respiratory rate, electrocardiogram (ECG) and vital signs (including body temperature) recording, and results of biochemistry, coagulation, hematology and urinalysis tests during screening as judged by the investigator.
- Non-smoker/non-user of nicotine containing products for at least 3 months prior to screening, to be confirmed by a urine cotinine dipstick test at screening and on Day -1 of the first session.
- Availability and willingness to complete the trial and follow the instructions of the investigator or trial-site personnel.
- Willing and able to adhere to the prohibitions and restrictions specified in the protocol
- Easy venous accessibility.
- Must have signed an Informed Consent Form (ICF) prior to screening, indicating that he understands the purpose of, and procedures required for the trial, and is willing to participate in the trial.
- Must agree to provide a blood sample for DNA research.
- Subject who is heterosexually active with a woman of childbearing potential must agree to use 2 effective methods of birth control (i.e., male condom with either female intrauterine device, diaphragm, cervical cap or hormone-based contraceptive), during the trial and for at least 90 days after receiving the last dose of trial medication. If the female sexual partner is postmenopausal for at least 2 years, or is surgically sterile (has had a total hysterectomy, bilateral oophorectomy, or bilateral tubal ligation/bilateral tubal clips without reversal operation), or otherwise is incapable of becoming pregnant, the birth control methods mentioned are not applicable, however, subjects should use a condom during the trial and for at least 90 days after receiving the last dose of trial medication to prevent unintended exposure via the ejaculate.
Subjects who had vasectomy and have a female partner of childbearing potential must use a male condom during the trial and for at least 90 days after receiving the last dose of trial medication.
Note: A male and female condom should not be used together due to risk of breakage or damage caused by latex friction.
Note: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the trial medication (during the trial and for at least 90 days after receiving the last dose of trial medication). The reliability of sexual abstinence needs to be evaluated in relation to the duration of the trial and the preferred and usual lifestyle of the subject.
Note: Subjects will be instructed that if their partner becomes pregnant during the trial this should be reported to the investigator. The investigator should also be notified of pregnancy occurring during the trial but confirmed after completion of the trial. In the event that a subject's partner is subsequently found to be pregnant after the subject is included in the trial, then consent will be sought from the partner and, if granted, any pregnancy will be followed and the status of mother and/or child will be reported to the sponsor after delivery.
- Must agree not to donate sperm during the trial and for at least 90 days after receiving the last dose of trial medication.
Exclusion Criteria
- History of or current clinically significant medical illness including (but not limited to) gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, endocrinologic, genitourinary, renal, hepatic, respiratory, inflammatory, neoplastic, or infectious disease, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the trial results.
- Clinically significant abnormalities of hematology or biochemistry (out o
Data sourced from ClinicalTrials.gov (NCT03634085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.