Novel Energy Metabolic Signaling Molecule With Therapeutic Potential

NCT04713319 | Completed Early Phase 1

• 1 other identifier: 2019_410211_2020
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

• Acute change in blood IL-6, insulin, and glucose after RH013001 or Placebo dose at Day7

  Immediately after morning (non-acute) blood sample therapeutic dose of RH013001 or placebo. Comparison of average response between RH013001 and placebo. Additional comparison to VO2max response (see pre-specified outcome below).

  45 minutes control blood sample

• Change in blood metrices from Day1 (0-control / baseline) to Day7

  Last dose 12 hours earlier = "non-acute". Paired comparison to Day1, measurements included energy metabolic and anti-inflammatory markers (first 3 days for recovery from VO2max), N in blinded placebo group was 0 for the first 7 days

  7 days

Secondary Outcomes (2)

• Global RNA-sequencing

  21 days

• Change in "non-acute" blood sample metrices from Day1 (baseline) to Day21

  21 days

Other Outcomes (1)

• Participants' Aerobic Capacity at Day1.

  10-20 + 30 minutes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

RH013001 (DGA)

ACTIVE COMPARATOR

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.

Drug: Panavital

Interventions

Panavital DRUG

In the morning and evening a dose of Placebo or D-glyceric acid (DGA) calcium salt dehydrate (Panavital) dissolved into 1.8 dl of water.

Also known as: D-glyceric acid calcium salt dehydrate

RH013001 (DGA)

Placebo OTHER

In the morning and evening a dose of Placebo or D-glyceric acid (DGA) calcium salt dehydrate (Panavital) dissolved into 1.8 dl of water.

Placebo

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy 50-60 year-old females and males

You may not qualify if:

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

Sponsors & Collaborators

• Petteri Hirvonen: lead
• University of Jyvaskyla: collaborator

Study Sites (1)

Faculty of Sports and Health Sciences, University of Jyväskylä

Jyväskylä, Central Finland, FI-40014, Finland

Location

Study Officials

• Heikki Kyröläinen, PhD

  University of Jyvaskyla

  STUDY DIRECTOR

• Petteri Hirvonen, M.Sc., MBA

  University of Jyväskylä, Replicon Health Oy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants and care providers were fully blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Scientific Officer

Model Details: Altogether a 25 day study with first four days non-blinded with water. There after 0-control blood samples. After the 0-control blinded treatments for 21 days (3 weeks). Study group apparently healthy 50-60 year old males and females (N=27).

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 19, 2021
• Study Start: October 4, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)