CompletedPhase 1

Clinical Study of ALT-BB4 to Determine Tolerance, Safety and Pharmacokinetics in Healthy Volunteer

South Korea290 participantsStarted 2022-01-18

Plain-language summary

A Phase I Study to Evaluate the Tolerance, Safety and Pharmacokinetics of ALT-BB4 in Healthy Volunteers

Who can participate

Age range19 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy volunteers aged ≥19 years at the time of Screening (Visit 1)
✓. Female subjects or male subjects' female partner must be menopausal or should have received a sterilization procedure or have agreed to use contraceptive methods during the study period, as defined below:
✓. WOCBP or females who have the last menstrual period within 12 months must have a negative serum or urine pregnancy test at Screening (Visit 1).
✓. Subjects who have voluntarily decided to take part in the study and able to comply with the study protocol
✓. Subjects who have no tattoo, acne, dermatitis, pigmentation or lesion on the administration site and who have no damage in the skin, so that they can receive the IP and allergy test
✓. Subjects determined eligible for the study through Screening tests (vital signs, physical examination, medical history and surgery history, ECG, and laboratory tests)
✓. Subjects with BMI no less than 18.5 kg/m2, no greater than 24.9 kg/m2

Exclusion criteria

✕. Subjects who have received or treated with following medications within the specified timeframe prior to Screening (Visit 1) or who are expected to receive them during the study period:
✕. Subjects who have prior history of clinically significant liver, kidney, nervous system, immune system, respiratory system, endocrine system, hematology/neoplasm, cardiovascular system, mental (mood disorder, obsessive-compulsive disorder), gastrointestinal disorders or surgical history
✕. Subjects with acute fever \> 37.5℃ within 7 days from the expected IP administration or showing symptoms suspecting acute diseases within 14 days from the expected IP administration
✕. Subjects who do not have normal blood pressure\*
✕. Subjects who persistently drink more than the weekly recommended alcohol units\* 14 g of alcohol content per unit is applied, which corresponds to 1 can (small bottle) of beer (5%), 350 mL of draft beer (5%), 1 cup (300 mL) of makgeoli, 1 glass (150 mL) of wine (12%), 1/4 bottle (90 mL) of soju (20%), and 1 shot (45 mL) of liquor (40%). Moderate amount of alcohol by age and gender is provided below:23) Age Recommended unit per week Adults (≥ 19 and \< 65 years) Male: 8 units/week Female: 4 units/week Elderly (≥ 65 years) Male: 4 units/week Female: 2 units/week
✕. Subjects of usual smoker (exceeding 10 cigarettes per day)
✕. Subjects who have a past history of autoimmune diseases (e.g.: rheumatoid arthritis, etc.) or active immune diseases that may affect the immune system \[e.g.: flu, cancer, Human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV) etc.\], diabetes mellitus, heart diseases, asthma, sinusitis, chronic urticaria, dermographism, or any skin conditions that may affect post-IP administration assessments (e.g.: Dermatitis, dermatomycosis and other skin diseases or tattoo)
✕. Subjects with known allergic reactions or hypersensitivity to bee sting or other common allergens or known contraindications to hyaluronidase, thimerosal (disinfectants) and EDTA

What they're measuring

Incidence Rate of Drug Allergy Following ID Injection of the IP

Timeframe: 2 days

Injection-site TEAEs (Treatment Emergent Adverse Events)

Timeframe: 4 weeks

Trial details

NCT IDNCT05232175

SponsorAlteogen, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-08-24

Results submitted2025-09-28

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