Novel Energy Metabolic Signaling Molecule With Therapeutic Potential (RH013001)

Replicon Health

Status and phase: Completed; Early Phase 1

Conditions: Healthy Participants

Treatments: Drug: Panavital; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04713319

2019_410211_2020

Details and patient eligibility

About

Altogether a 25-day study. First 4 days non-blinded with water before 0-control blood samples (Day0). Thereafter blinded for 21 days (3 weeks). Study group was apparently healthy 50-60 -year-old males and females (N=27).

Full description

Blinded 21-day period was divided into two sub-periods (7 days and 14 days) and it included 3 measurement days. All measurements were on the same day of each week to facilitate maximal comparability (Day0, Day7 and Day21). Additionally on Day0 and Day7 there were acute measurements 45 minutes after morning "non-acute" resting and fasting blood samples. (In a "non-acute" measurement last dose of Panavital or placebo was taken 12 hours before the "non-acute" blood sample collected next morning .)

First week started with Day0 baseline measurements and immediately thereafter a strenuous VO2max test with 2 recovery days thereafter. After full recovery a 4-day blinded Panavital regimen. Last "non-acute" dose on Day6 was taken 12 hours before Day7 morning blood sample. At Day7 an acute 45 min placebo comparison was conducted.

Thereafter a 14-day follow-up period with halved Panavital dose or Placebo. Altogether 5 arterial blood samples were withdrawn. Three fasting and resting "non-acute" samples were taken in the morning before any treatments at Day0, Day7 and Day21. Two acute samples were collected after the VO2max (Day1) and after acute Panavital or placebo doses (Day7).

Additionally 5 fingertip blood samples for glucose (and lactate) were taken at the same time as arterial samples (Day0 and Day7) and one fingertip sample was taken immediately at the end of VO2max.

Enrollment: 27 patients

Sex: All

Ages: 50 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy 50-60 year-old females and males

Exclusion criteria

• history of cardiovascular diseases, overweight (BMI >32)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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27 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Ten participants were randomly selected to the placebo group. Calcium chloride (E509) dissolved into water. Extremely small equimolar calcium dose with the test item.

Treatment:

Other: Placebo

RH013001 (DGA)

Active Comparator group

Description:

D-glyceric acid (DGA) calcium salt dehydrate (RH013001) dissolved into 1.8 dl of water. Effective dose of DGA was 3.33 mg / kg body weigh for the first 4 days. Thereafter the dose was reduced to half for the 14 days follow up period. Frequency: 2 times a day.

Treatment:

Drug: Panavital