Healthy Adults Clinical Trials, Phase I as Topic Drug Tolerance Dose-Response Relationship, Drug Pharmacodynamics DNA, Recombinant / administration &
Conditions
Interventions
Rejuvenating DNA by Genomic Stability Molecule to Strengthen DNA (REDGEM-S-DNA)
Active ingredient: Box A of High Mobility Group Box 1 Protein (HMGB1) plasmid [Box A plasmid coated with Calcium-Phosph
Experimental Drug
REDGEM-S-DNA
Sponsors
REDGEM MOLECULE. Co.,LTd.
Eligibility
Sex/Gender
All
Age
20 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Adult healthy participants between 20-70 years of age for Cohort 1-5 and 60-70 years of age for Cohort 6-7, at the time of signing the informed consent
Exclusion criteria
Exclusion criteria: 1. Participants with uncontrolled medical comorbidities 2. Participants who have a history of allergy, hypersensitivity, or intolerance to any medications, components, or excipients of the Investigational Product (IP) 3. Participants with immunosuppressive illness or immunodeficient state or at high-risk of opportunistic infections including: History of solid or bone marrow transplantation, Asplenia ,Long-term corticosteroid or immunosuppressive drug users, Neutropaenia, Chronic kidney disease stage 3,Severe malnutrition (e.g. Kwashiorkor or Marasmus),Undergoing intensive care or invasive procedures, Viral-specific high-risk groups include those at risk of severe disease from influenza, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), cytomegalovirus, and adenovirus 4. Participants with a history of malignancy with potential risk for recurrence after curative treatment, or current diagnosis of or treatment for cancer [exceptions are squamous and basal cell carcinomas of the skin and treated uterine cervical carcinoma in situ, at the discretion of the Principal Investigator (PI)] 5. Participants with a bleeding disorder considered a contraindication to IM injection or phlebotomy, at the discretion of the PI 6. Participants with a history of cerebral venous sinus thrombosis, heparin-induced thrombocytopaenia, thrombosis with thrombocytopaenia syndrome (TTS), antiphospholipid syndrome, or capillary leak syndrome 7. Participants with ongoing systemic infection 8. Participants with significant liver disease with Aspartate Aminotransferase or Alanine Transaminase 9.9. Participant who, in the PI judgement, is not in a stable condition and by participating in the study could adversely affect the safety of the participant, interfering with adherence to study requirements or evaluation of any study endpoint. This may include a participant with ongoing acute diseases, psychiatric disorders, severe infections, autoimmune disease, laboratory abnormality or serious medical conditions 10. Participants who are currently enrolled in another interventional clinical study, or who have participated in such a study/received any investigational medicinal product (IMP) or investigational device within the past 30 days or within five half-lives of the investigational product (whichever is longer), will be excluded. 11. Participation in purely observational studies, involving no investigational treatment or device, is permitted. 12. Occult infection including chronic sinusitis, and pulmonary tuberculosis 13. Uncontrolled diabetes evidenced by HbA1c > 7 %, or current use of insulin 14. Uncontrolled hyperlipidaemia evidenced by total cholesterol > 300 mg/dL 15. Poorly controlled blood pressure (BP) (systolic BP > 160 and/or diastolic BP > 100 mmHg) 16. Participants with known or suspected clinically significant pulmonary hypertension (either pre-, post-, or mixed pre- and post-capillary)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of REDGEM-S-DNA in healthy adult participants 28 days Descriptive | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of REDGEM-S-DNA 28 days Descriptive | — |
Countries
Thailand
Contacts
Public ContactApiwat Mutirangura
REDGEM MOLECULE CO., LTD.
Outcome results
None listed