None listed
Conditions
Interventions
Intervention1: Sovateltide for Injection: 0.3 mcg/kg single dose IV bolus over 1 minute Strength per vial 30 mcg Manufactured by: Gufic Biosciences Ltd National Highway No 8 Near GRID Kabilpore Navsar
Sponsors
Gufic Biosciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Normal healthy adult human Participant (Male and/or non-pregnant, non-lactating female) aged between of 18-45 years. (Both inclusive) 2. Body weight of 50 kg or above. 3. Normal BMI 18.50 to 29.99 kg/m2 (both inclusive) 4. Willingness to provide written Informed Consent to participate in the study. 5. Participants willing to adhere to the protocol requirements as evidenced by written informed consent approved by ethics committee. 6. Volunteer is able to communicate well with the investigator. 7. Availability of Participant for the entire study period and willingness to adhere to protocol requirements as evidence by written informed consent. 8. Participant must be in good health as determined by medical history, vital signs (blood pressure, body temperature, pulse rate, respiratory rate) and physical examination or showing no clinically significant abnormalities in the opinion of Principal/Clinical Investigator or designated physicians. 9. Normal or clinically non-significant result of Chest X ray (if required) and 12-lead ECG of the participants. 10. Participant having clinical laboratory tests (Biochemistry, Hematology, and Urinalysis & Serology) results within normal reference range or evaluated as non-clinically significant by the investigator/physician. 11. Participant found negative in Breath alcohol test. 12. Participants that can provide adequate evidence of their identity. 13. Participants will fast overnight from at least 10.00 hours (hrs.) before dosing and for at least 04.00 hrs. post-dose in each study period. 14. Participants are non-alcoholic and non-smoker. 15. The Participant willing to abstain from food and drinks, which may interact with circulatory, gastrointestinal, hepatic or renal function (e.g. alcoholic drinks or certain fruit juices such as grapefruit juice) for 72.00 hours prior to the check-in of period I to throughout the study. 16. Ability and willingness to abstain from methyl xanthine-containing beverages or food (coffee, tea, coke, chocolate, power drinks ) and grapefruit juice from 72.00 hrs. Prior to admission of period I to throughout the study. 17. A negative urine screen result for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine and morphine). 18. Participants willing to not participate in any clinical research study and/or blood donations till 180 days after completion of the study and during the study. 19. Female participants: Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or Hysterectomy has been performed on the Participant) or Female of childbearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams; jellies, diaphragm, and intrauterine device (IUD) or abstinence. Female of childbearing potential must have a negative urine pregnancy test performed within 07 days prior to initiation of the study. Female Participant must have a negative-hCG pregnancy test prior to check-in of each period. 20. Female participants commit to maintaining effective contraceptive measures throughout the study period and fo
Exclusion criteria
Exclusion criteria: 1.Known allergy or hypersensitivity to Sovateltide, endothelin receptor modulators, peptide drugs, or excipients. 2.History of anaphylaxis or severe allergic reactions. 3.Anemia with hemoglobin less than 12 g per dL 4.Body Temperature less than 97.0 99.5 F 5.Radial Pulse rate less than 60 per min or above 100 per min 6. Those with a past or existing history of the following diseases or chronic and severe illnesses including but not limited to the cardiovascular system, digestive system, urogenital system, respiratory system, blood system, endocrine system, immune system, mental nervous system, skeletal system, etc., that researchers believe are still clinically significant; Especially for participants with gastrointestinal dysfunction, peptic ulcer, gastrointestinal surgery, and other diseases that affect drug absorption, distribution, metabolism, and excretion. 7. Ingestion of a medicine at any time within 14 days before dosing in Single period. In any such case Participant selection will be at the discretion of the PI or CI and medicine taken will be recorded. 8. Any history or presence of asthma including aspirin induced asthma or NSAID induced urticarial. 9. People with positive results of any test for human immunodeficiency virus HIV antibody, hepatitis B surface antigen HBsAg, hepatitis C virus HCV antibody. 10. A recent history of alcoholism 120 mL or more per day and consumption of alcohol within 24 hours prior to receiving study drug. 11. History or presence of significant smoking 09 or more than 09 cigarettes or beedis per day or could not abstain from smoking during study 12. Maintenance therapy with any drug. 13. Incapable of understanding the informed consent information. Poor mental development or impaired cerebral function. 14. Participants who have participated in another clinical study in the past 03 months prior to commencement of this study. 15. Participation in a drug research study within 90 days of screening. 16. Difficulty with donating blood. 17. Donation of blood/ Plasma 01 units: 350 mL within 90 days for male and female prior to receiving the first dose of study drug. 18. Refuse to abstain from food for at least 10.00 hr. prior to drug administration and for at least 04.00 hr. after drug administration in each period. 19. Refuse to abstain from fluid for at least 01.00 hr. prior to drug administration and until 01.00 hr. after drug administration 20. Abnormal diet pattern for whatever reason e.g.low sodium, fasting, and high protein diets during the four weeks preceding the study. 21. Participant consumed tobacco or tobacco containing products, pan or pan masala, gutkha, masala containing beetle nut and tobacco for at least 72.00 hours prior to initiation of the study and throughout the study. 22. Participant consumed caffeine and or xanthine-containing foods or beverages i.e., coffee, tea, chocolate, and caffeine-containing sodas, colas, etc. and grape fruit juice and poppy containing foods for at least 72.00 hours prior to initiation of the study and throughout the study 23. Major illness during the 90 days before screening 24. Found positive in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Cmax Maximum measured plasma concentration 2. AUC0-t Area under curve from time 0 to last measurable concentration 3. AUC0-inf Area under curve from time 0 to infinityTimepoint: Pre-dose and at 20 time points: 00.02, 00.03, 00.04, 00.05, 00.08, 00.10, 00.17, 00.25, 00.33, 00.50, 00.67, 00.83, 01.00, 01.25, 01.50, 02.00, 03.00, 04.00, and 06.00 hours post-dose in each period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Tmax, t1/2, Kel, AUC_Extrap, AUCt AUCinf ratio 2. Safety and tolerability AEs, vital signs, laboratory parameters, ECG Timepoint: 1. Tmax, t1/2, Kel, AUC_Extrap, AUCt/AUCinf ratio Pre-dose and at 20 time points up to 6 hours post-dose in each period 2. Safety and tolerability AEs, vital signs, laboratory parameters, ECG: Throughout the study from screening to followup | — |
Countries
India
Contacts
Public ContactDr Samvveda Samel
Vivotech Research Lab Pvt Ltd
Outcome results
None listed