- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05232175
Clinical Study of ALT-BB4 to Determine Tolerance, Safety and Pharmacokinetics in Healthy Volunteer
A Phase I Study to Evaluate the Tolerance, Safety and Pharmacokinetics of ALT-BB4 in Healthy Volunteer
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of
- Research Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Common
- 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:
- Post-menopausal female subjects or male subjects' female partners (non-drug induced amenorrhea for at least 12 months or confirmed diagnosis with menopause)
- Female subjects or male subjects' female partners who have received a sterilization procedure (removal of ovary and/or uterus)
- Subjects who have agreed to practice total abstinence during the study period [For female subjects, periodic abstinence (e.g., ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception.]
- When female subjects or male subjects' female partners are women of childbearing potential (WOCBP) who have not received a sterilization procedure, they must agree to use of following contraceptive methods:
- Hormones (implantable, patch, and oral)
- Intrauterine device (IUD)
- Double barrier methods (concomitant use of two of following contraceptive methods: male condom, female condom, cervical cap, diaphragm, sponge, spermicide) (However, concomitant use of male condom and female condom is excluded from double barrier methods.)
- 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)
Part II-A
- Subjects with BMI no less than 18.5 kg/m2, no greater than 24.9 kg/m2
Exclusion Criteria:
Common
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:
- Within 1 month: Hyaluronidase, Chemotherapeutic agent, non-steroidal anti-inflammatory drugs (NSAIDs; e.g.: Aspirin, Aceclofenac, etc.), penicillins antibiotics (e.g.: Amoxicillin, Ampicillin, etc.), cephalosporins antibiotics (e.g.: Cefaclor, Cefadroxil, Cefixime, etc.), sulfonamides antibiotics (e.g.: Sulfadiazine, Sulfamethoxazole, etc.), quinolones antibiotics (e.g.: Ciprofloxacin, Levofloxacin, etc.), Glucocorticosteroid, Immunosuppressive agent
- Within 14 days: Antihistamine (e.g.: Chlorpheniramine, Hydroxyzine, Ketotifen, etc.)
- 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*
*Range of normal blood pressure is defined as systolic and diastolic blood <120/80 mmHg in accordance with 2018 Korean Society of Hypertension Guidelines for the Management of Hypertension24) (however, Pre-hypertension (≥ 130/80) is excluded that may occur in normotension).
- 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
- Subjects with hypersensitivity to the IP or its ingredients or a history of anaphylaxis
- Past history of drug abuse
- Subjects who have participated in other clinical trials within 6 months prior to the expected IP administration
Others determined ineligible for the study participation in the opinion of investigator
Part II-A
Subjects who have been treated with a drug-metabolizing enzyme inducers and inhibitors*25), 26) within 30 days prior to the IP administration
* Example: Phenytoin, Carbamazepine, Barbiturates, Rifampicin, Griseofulvin, Cimetidine, Disulfiram, Erythromycin, Ketoconazole, Fluconazole, Itraconazole, Valproic acid, Isoniazid, Ciprofloxacin, Omeprazole, Clarithromycin, Quinidine, Sulfonamides, etc.
- Subjects who have significant bleeding or blood loss within 60 days prior to Screening (Visit 1)
- Subjects who have donated whole blood within 60 days or donated blood by apheresis within 14 days or received transfusion within 14 days prior to Screening (Visit 1)
- Subjects who have consumed grapefruit juice28) within 7 days prior to Screening (Visit 1)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part I (Allergy assessment) - ALT-BB4
|
Recombinant Hyaluronidase
|
Placebo Comparator: Part I (Allergy assessment) - 0.9%NaCl
|
Normal Saline
|
Experimental: Part II-A (PK assessment)
|
Recombinant Hyaluronidase
|
Experimental: Part II-B (Safety assessment) - ALT-BB4
|
Recombinant Hyaluronidase
|
Placebo Comparator: Part II-B (Safety assessment) - 0.9% NaCl
|
Normal Saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence rate of drug allergy following ID injection of the IP
Time Frame: 2 days
|
Subject developing either immediate or delayed allergic reaction are considered to have drug allergy.
|
2 days
|
Safety and tolerability assessment following SC injection of the IP
Time Frame: 4 weeks
|
Incident rate of adverse events, including systemic and administration site-related adverse events.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ALT-BB4-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Health, Subjective
-
Istanbul University - Cerrahpasa (IUC)Not yet recruitingHealth, Subjective
-
Bahçeşehir UniversityNot yet recruiting
-
BMI KoreaCompletedHealth, SubjectiveKorea, Republic of
-
Tel Aviv UniversityCompletedHealth, SubjectiveIsrael
-
Hanmi Pharmaceutical Company LimitedCompletedHealth, SubjectiveKorea, Republic of
-
Sihuan Pharmaceutical Holdings Group Ltd.CompletedHealth, Subjective
-
Chulalongkorn UniversityNot yet recruiting
-
Prince Sattam Bin Abdulaziz UniversityCompletedHealth, SubjectiveSaudi Arabia
-
Çankırı Karatekin UniversityCompleted
-
Jiangsu HengRui Medicine Co., Ltd.Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineCompleted
Clinical Trials on ALT-BB4
-
Masonic Cancer Center, University of MinnesotaCompletedFIGO Stage III and IV Ovarian Cancer | FIGO Stage III and IV Fallopian Tube Cancer | FIGO Stage III Primary Peritoneal CancerUnited States
-
John SampsonCompleted
-
Masonic Cancer Center, University of MinnesotaUniversity of MinnesotaWithdrawnSecondary Acute Myeloid Leukemia | Myelodysplastic Syndrome | Treatment-Related Acute Myeloid Leukemia | High-Risk Acute Myeloid LeukemiaUnited States
-
Altor BioScienceCompletedHealthyUnited States
-
Altor BioScienceNational Cancer Institute (NCI)CompletedAdvanced Solid TumorsUnited States
-
Synvista Therapeutics, IncCompletedCoronary Artery Disease | DiabetesUnited States
-
Aqualung Therapeutics Corp.Not yet recruitingAcute Respiratory Distress Syndrome (ARDS)
-
Altimmune, Inc.Completed
-
Masonic Cancer Center, University of MinnesotaCompletedLymphoma | Chronic Lymphocytic Leukemia (CLL) | Myelodysplastic Syndromes (MDS) | Myeloma | Acute Lymphoblastic Leukemia (ALL) | Acute Myelogenous Leukemia (AML) | Chronic Myelogenous Leukemia (CML)United States
-
Altor BioScienceNational Cancer Institute (NCI)UnknownRelapsed or Refractory Multiple MyelomaUnited States